Applies to albuterol / budesonide: inhalation aerosol.
Warning
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using albuterol and budesonide inhalation and call your doctor at once if you have trouble breathing, coughing, and wheezing.
Call your doctor at once if you have:
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heart problems, high blood pressure, or fast heart rate;
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low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
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decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
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signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
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eye problems, such as glaucoma and cataracts; or
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bone problems, such as bone pain.
Common side effects may include:
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sores or white patches in your mouth or throat, trouble swallowing;
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headache;
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cough; or
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hoarse or deepened voice.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to albuterol / budesonide: inhalation aerosol.
General
The most common adverse reactions with a frequency of 1% or greater were headache, oral candidiasis, cough, and dysphonia.[Ref]
Cardiovascular
-Arrhythmias included atrial fibrillation and supraventricular tachycardia.[Ref]
Postmarketing reports: Arrhythmia, extrasystole, hypertension, myocardial ischemia, palpitation, peripheral vasodilatation, syncope, tachycardia, tremor[Ref]
Dermatologic
Postmarketing reports: Ecchymosis, skin bruising[Ref]
Endocrine
Postmarketing reports: Glucocorticosteroid effect[Ref]
-Glucocorticosteroid effect included hypofunction of the adrenal gland and reduction of growth rate.[Ref]
Gastrointestinal
-Oral candidiasis also included those reactions reported under the preferred term oropharyngeal candidiasis.[Ref]
Common (1% to 10%): Oral candidiasis
Postmarketing reports: Diarrhea, dyspepsia, nausea, vomiting[Ref]
Immunologic
-Immediate and delayed hypersensitivity reaction included anaphylactic reaction, angioedema, bronchospasm, rash, contact dermatitis and urticaria.[Ref]
Postmarketing reports: Delayed hypersensitivity reaction, immediate hypersensitivity reaction[Ref]
Metabolic
Postmarketing reports: Hypokalemia, metabolic acidosis[Ref]
Musculoskeletal
Postmarketing reports: Arthralgia, asthenia, fracture, hypertonia, musculoskeletal pain, muscle cramps, myalgia[Ref]
Nervous system
-Psychiatric symptoms included psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, behavioral disturbances, and anxiety.[Ref]
Common (1% to 10%): Headache
Postmarketing reports: Central nervous system stimulation, dizziness, hyperactivity, insomnia, migraine, psychiatric symptoms, taste perversion[Ref]
Ocular
Postmarketing reports: Cataracts, glaucoma, increased intraocular pressure[Ref]
Other
Postmarketing reports: Fever, gastroenteritis, laryngitis, nasopharyngitis, otitis media, pharyngitis, respiratory tract infection, sinusitis, weight gain[Ref]
Respiratory
Common (1% to 10%): Cough, dysphonia
Postmarketing reports: Rhinitis, nasal congestion, throat irritation, oropharyngeal edema, upper respiratory inflammation, drying or irritation of the oropharynx, flu syndrome[Ref]
